Depression Clinical Trial
— PMHSOfficial title:
Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India
NCT number | NCT05485701 |
Other study ID # | 10-20 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | August 31, 2026 |
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
Status | Recruiting |
Enrollment | 2332 |
Est. completion date | August 31, 2026 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: For Phase 1 (qualitative study) and Phase 2 (validation study): Pregnant women: - Aged 18 to 45 years - Currently pregnant (any trimester) - Willing and able to give informed consent Post-partum women: - Aged 18 to 45 years - Currently post-partum (between 1-12 months postpartum) - Willing and able to give informed consent Non-perinatal women: - Aged 18 to 45 years - Not currently pregnant and not given birth in the past 12 months - Willing and able to give informed consent For Phase 3 (prospective cohort study): Perinatal women: - Aged 18 to 45 years - In early pregnancy (estimated gestational age <20 weeks) at recruitment - Not planning to relocate for the duration of the study period - Willing and able to give informed consent - Expressed a willingness to continue to participate for the four planned visits Non-perinatal women: - Aged 18 to 45 years - Not currently pregnant and not given birth in the last 12 months - Not planning to relocate for the duration of the study period - Willing and able to give informed consent - Expressed a willingness to continue to participate for the four planned visits Exclusion Criteria: The participant may not enter the study if: - They have an acutely severe psychiatric illness which impairs their ability to take part in the study - They are not willing or able to provide informed consent Other than for current severe psychiatric illness which affects ability to participate in the study, we will not exclude any participant on the basis of current or prior physical, psychological or psychiatric co-morbidities so long as she is willing to participate, her ability to take part is not compromised and her ability to give informed consent is not impaired by these conditions. |
Country | Name | City | State |
---|---|---|---|
India | National Institute of Mental Health and Neuro Sciences | Bengaluru | Karnataka |
India | Dr Rajendra Prasad Government Medical College | Kangra | Himachal Pradesh |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Dr. Rajendra Prasad Government Medical College, National Institute of Mental Health and Neuro Sciences, India |
India,
Fellmeth G, Kishore MT, Verma A, Desai G, Bharti O, Kanwar P, Singh S, Thippeswamy H, Chandra PS, Kurinczuk JJ, Nair M, Alderdice F. Perinatal mental health in India: protocol for a validation and cohort study. J Public Health (Oxf). 2021 Oct 8;43(Suppl 2):ii35-ii42. doi: 10.1093/pubmed/fdab162. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders | These will be themes emerging from focus groups with women around awareness of perinatal mental disorders and acceptability of screening. | To be completed by August 2022 | |
Primary | Phase 2: Psychometric properties of screening tools for common mental disorders | The psychometric properties (sensitivity, specificity, area under the receiver operating curve, optimal cut-off and accuracy) of eight screening tools in Kannada and Hindi will be established among three groups of women: pregnant, post-partum and non-perinatal. | September 2022 - August 2023 | |
Primary | Phase 3: Point prevalence, period prevalence and incidence (with 95% confidence intervals) of common mental disorders among perinatal and non-perinatal women | During the cohort study, prevalence and incidence of mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed. | September 2023 - August 2024 | |
Primary | Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women | During the cohort study, risk factors associated with mental disorders (depression, anxiety, PTSD, somatisation and suicidality) will be assessed. | September 2023 - August 2024 |
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